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Augustine Therapeutics Raises EUR 17 Million in a Series A First Closing to Advance Lead Candidate Into Clinical Development in Neurological Diseases

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Augustine Therapeutics has secured EUR 17 million ($18.5 million) in the first closing of its Series A funding round. The financing was led by Asabys Partners, with participation from Eli Lilly and Company, and the Charcot-Marie-Tooth Research Foundation, among others.

The funds will advance AGT100216, a selective HDAC6 inhibitor, into a Phase 1/2 clinical trial in 2025, targeting neurological diseases like Charcot-Marie-Tooth and chemotherapy-induced peripheral neuropathies. Additional funds will support pipeline development and expand the executive and R&D team.

Gerhard Koenig has been appointed as Executive Chairman of the Board, while Clara Campàs from Asabys Partners has joined the Board of Directors.

Positive
  • Raised EUR 17 million ($18.5 million) in Series A funding.
  • AGT100216 to enter Phase 1/2 clinical trial in 2025.
  • Participation from prominent investors like Eli Lilly and Company.
  • Funds will also support the development of next-generation drug candidates.
Negative
  • Clinical trial for AGT100216 won't begin until 2025.

Insights

The Series A funding of EUR 17 million (approximately USD 18.5 million) is substantial for a biotech firm at this stage. This capital infusion provides Augustine Therapeutics with the necessary runway to advance its lead candidate, AGT100216, into a Phase 1/2 clinical trial by 2025. It's notable that renowned entities like Asabys Partners and Eli Lilly are involved, underscoring investor confidence.

From an investor's perspective, the involvement of these established firms could be seen as a validation of Augustine's technology and market potential. However, one must consider the inherent risks associated with clinical trials, especially in the early stages. Failure in these trials could significantly impact Augustine's valuation and investor returns.

Additionally, the biotech space is capital-intensive and often requires several rounds of funding before achieving profitability. Investors should be prepared for potential dilution in future fundraising events. The positive side is that the funds are earmarked not only for clinical trials but also for expanding the R&D and executive teams, which could catalyze further innovation and growth.

AGT100216, Augustine’s lead candidate, targets the HDAC6 enzyme—a promising but complex target in neurological disorders. The compound’s potential to modulate axonal transport and provide neuroprotection is particularly exciting, especially for conditions like Charcot-Marie-Tooth (CMT) and chemotherapy-induced peripheral neuropathy (CIPN).

Preclinical data showing the reversal of disease phenotypes and axonal integrity restoration are promising, but we should temper our expectations. The transition from preclinical to human trials is fraught with challenges and many candidates that show preclinical promise fail in human studies.

The unique mechanism-of-action and the selective nature of AGT100216 could offer a competitive edge over existing HDAC6 inhibitors. However, the effectiveness and safety profile in humans remain to be validated. If successful, AGT100216 could potentially disrupt the current treatment paradigms for several neurodegenerative and cardiometabolic diseases.

The neurodegenerative and cardiometabolic disease markets are substantial, with high unmet medical needs. Conditions like ALS, CMT and CIPN currently have limited treatment options, creating a significant opportunity for effective new therapies. Augustine’s focus on a unique generation of HDAC6 inhibitors could position it favorably in these markets. The differentiation based on chemical distinctiveness and selectivity of their inhibitors is a compelling selling point.

Market penetration will be contingent on several factors: successful clinical trials, regulatory approvals and strategic partnerships. The involvement of Eli Lilly might provide Augustine with advantageous market insights and potential pathways for future collaborations or acquisitions.

However, the competitive landscape is evolving and other companies are also developing HDAC6 inhibitors. Augustine will need to demonstrate clear clinical advantages to capture market share. Moreover, the presence of a strong consortium of investors helps bolster market confidence but also sets high expectations for clinical and commercial milestones. Retail investors should monitor trial results closely and be aware of the competitive developments in this space.

  • Proceeds will advance lead candidate AGT100216, a peripherally restricted and selective HDAC6 inhibitor, into a first-in-human clinical Phase 1/2 study
  • Gerhard Koenig appointed as executive chairman of Augustine's Board of Directors

LEUVEN, Belgium--(BUSINESS WIRE)-- Augustine Therapeutics, a pioneering biotech company focused on novel treatments for neurodegenerative and cardiometabolic diseases, today announced that it has raised EUR 17 million (USD 18.5 million) in the first closing of its Series A round. The financing was led by Asabys Partners, with participation from Eli Lilly and Company, and the US-based Charcot-Marie-Tooth Research Foundation. Current investors AdBio partners, V-Bio Ventures, PMV, VIB and Gemma Frisius Fund also joined the round.

Augustine Therapeutics is developing best-in-class, novel, potent and subtype-selective small-molecule inhibitors of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, a class II histone deacetylase. HDAC6 is a well-known molecular target with strong biological rationale for neurological disorders and high therapeutic potential in cardiometabolic disease. Inhibition of HDAC6 plays a leading role in axonal protection and regeneration by controlling the efficiency of internal axonal transport. Augustine’s novel generation of HDAC6 inhibitors (HDAC6i) are chemically distinct and superior to the first generation hydroxamate-based inhibitors developed so far, allowing them to safely and selectively reverse and inhibit the pathophysiological changes associated with neuromuscular diseases such as Charcot-Marie-Tooth (CMT), peripheral neuropathies induced by chemotherapies (CIPN), as well as neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS).

The proceeds from this first close will be used to advance Augustine’s lead candidate, AGT100216, into a Phase 1/2 first-in-human clinical trial in 2025. AGT100216 is a peripherally restricted and selective small molecule HDAC6i with a unique mechanism-of-action that has strong potential in CMT and CIPN. The financing will further support the development of the company’s pipeline, including the advancement of its next-generation drug candidates with additional peripheral-restricted or brain penetrant properties for cardiometabolic and neurodegenerative diseases, as well as fund the expansion of the Augustine executive and R&D team.

“The support from both new and existing investors in this first closing is a reflection of the tremendous efforts and scientific excellence of our team in advancing a unique pipeline of potential breakthrough therapeutics for patients,” said Sylvain Celanire, CEO of Augustine Therapeutics. “Our HDAC6 inhibitors have unique properties designed to achieve meaningful benefits for patients with neurodegenerative and cardiometabolic diseases. Our first clinical candidate, AGT100216, has demonstrated impressive preclinical efficacy in CMT studies highlighting its ability to halt disease progression, significantly reverse the disease phenotype and rescue axonal integrity in a dose-dependent manner. We are looking forward to capitalizing on our unique pipeline with the strategic insights we are gaining from our Board and Executive Chairman Gerhard Koenig.”

Clara Campàs, Founding and Managing Partner at Asabys Partners, said: “Augustine’s molecules are unique, selective and potent, providing a competitive advantage in modulating a validated target with potential impact in a large variety of indications. Augustine’s novel generation of chemically distinct HDAC6 inhibitors are unprecedented and have the potential to overcome some of the typical limitations of other HDAC6 inhibitors currently being tested in early clinical development. We are thrilled to have joined a strong consortium of investors alongside Eli Lilly and Company, the current investors and Augustine’s exceptional team to further develop these molecules to clinical proof of concept.”

In conjunction with the financing, Clara Campàs, Founding and Managing Partner at Asabys Partners, has joined Augustine Therapeutics’ Board of Directors. Isabel Jiménez, Associate at Asabys, and a representative from Eli Lilly and Company, will join as Board Observers.

In addition, Augustine Therapeutics announced today the appointment of Gerhard Koenig as Executive Chairman of its Board of Directors. Gerhard Koenig has been a Non-Executive Director on Augustine’s Board since May 2022, and currently serves as CEO and Founder of Arkuda Therapeutics, a Boston-based biotech company, focused on the development of lysosomal function enhancers in neurodegenerative diseases. Gerhard is also a Board Member of Vigil Therapeutics (NASDAQ: VIGL) focused on rectifying Microglial dysfunction in neurodegenerative diseases.

Full bios of the complete Board of Directors can be found on the company’s website via this link.

About Augustine Therapeutics
Augustine Therapeutics is a Belgian biotech company, founded in 2019 and a spin-off company of VIB-KU Leuven. The company is building a portfolio of best-in-class small molecules HDAC6 inhibitors for the treatment of severe peripheral and CNS diseases. Its scientific foundation originates from the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven Center for Brain and Disease Research, tackling the underlying mechanism of axonal degeneration of peripheral nerves through selective HDAC6 inhibition. For more information visit www.augustinetx.com.

About Asabys Partners
Asabys Partners (www.asabys.com) is a venture capital firm specialized in the healthcare sector, founded in 2018 by Josep Ll. Sanfeliu and Clara Campàs, participated by Alantra and with the support of Banc Sabadell as anchor investor. Asabys invests in highly innovative and disruptive companies covering unmet medical needs in the biopharma and healthtech verticals. The firm’s investment in the company comes from its vehicles Sabadell Asabys Health Innovation Investments II, FCR and Sabadell Asabys Health Innovation Investments 2B, SCR SA.

About Eli Lilly and Company
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today, our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. C-LLY

About the CMT Research Foundation
CMTRF (www.cmtrf.org) is a patient-led, non-profit focused on delivering treatments and cures for CMT. The foundation identifies significant obstacles or deficiencies impeding progress towards a cure and seeks out collaborators to address these issues. It's their mission to raise funds to invest in promising science with high potential of leading to treatments and cures. Founded by two patients who are driven to expedite drug delivery to people who live with CMT, the 501(c)(3) federal tax-exempt organization is supported by personal and corporate financial gifts.

Sylvain Celanire

Chief Executive Officer

Email: info@augustinetx.com

For Media:

Trophic Communications

Stephanie May or Eva Mulder

augustine@trophic.eu

+31 6 52 33 15 79

Source: Augustine Therapeutics

FAQ

What amount did Augustine Therapeutics raise in its Series A round?

Augustine Therapeutics raised EUR 17 million ($18.5 million) in the first closing of its Series A round.

When will Augustine Therapeutics' AGT100216 enter clinical trials?

Augustine Therapeutics' AGT100216 is expected to enter Phase 1/2 clinical trials in 2025.

Who led the Series A funding for Augustine Therapeutics?

The Series A funding was led by Asabys Partners, with participation from Eli Lilly and Company and the Charcot-Marie-Tooth Research Foundation.

What is AGT100216?

AGT100216 is a peripherally restricted and selective HDAC6 inhibitor aimed at treating neurological diseases like Charcot-Marie-Tooth and chemotherapy-induced peripheral neuropathies.

Who is the newly appointed Executive Chairman of Augustine Therapeutics?

Gerhard Koenig has been appointed as the Executive Chairman of Augustine Therapeutics' Board of Directors.

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